Standard Homeopathic issued the recall at the request of the U.S. Food and Drug Administration (FDA), which found inconsistent amounts of belladonna alkaloids in the tablets that can be different from what is listed on the packaging.

“There is no known safe dose or toxic dose of belladonna in children because of the many factors that affect it,” FDA stated to Standard Homeopathic.

From 2006 to 2016, FDA collected reports of “adverse events” in more than 370 children who had used Hyland’s homeopathic teething tablets or gel. Agency records show at least eight cases in which babies died after taking Hyland’s products, though the FDA says the question of whether those products caused the deaths is still under review.

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